The present invention relates to an analgesic and refreshing herbal composition useful dentrifrices and a process for the preparation of the same.
1. Background of the Invention
Toothache is very common in human being of all age groups of both sex. Dental caries are caused due to the combined action of lactic acid, proteolytic enzymes and bacteria present in the oral cavity. Deep cavity in tooth, as a result of inflammation of the pulp causes pulpits. The root end abscess occurs in a tooth that has a dead nerve. Inflammation and swelling of the gingiva produce a deeper crevice or trough leading to gingivals abscess a periodontal disease. The application of tooth paint to the affected part produces counter irritation and local anaesthetic action, which in turn stops feeling sensation of pain.
2. Prior Art Relating to the Invention
Various formulations of such preparations available in market have been published in Indian Pharmaceutical Guide (1994) 32nd Edition published by Pamposh Publication, New Delhi, India. In seven formulations/preparations essential oil or isolates have been used as the major ingredients. Dabur India Ltd. markets two preparations, one having clove oil while the other named xe2x80x9cDar-Dantxe2x80x9d a mixture of phenol, camphor, menthol and ajowan oil. Baidyanath Ayurved Bhawan also has two preparationsxe2x80x94xe2x80x9cDant Dard Ki Dawaxe2x80x9d and xe2x80x9cDenta Besharixe2x80x9d. The first one has phenol, camphor, Thymol, chlorobutol (I.P.), clove oil and chloroform while the second one has tannic acid, phenol, clove oil, cinnam m oil and glycerol (I.P.). Dentacare by Kothari Laboratory have borax, methyl salicylate, clove oil, tannic acid, potassium iodide, camphor and phenol. Dentolin by Jupiter Pharmaceuticals Pvt. Ltd. have creosote oil, clove oil, tincture myrrh, tincture iodine, procaine H, camphor, glycerin and chloroform while Dentosol by Synthochem have camphor, menthol, Thymol and katha.
All these formulations contain essential oil or their isolates as their major ingredients. xe2x80x9cDar-Dantxe2x80x9d (from Dabur India Ltd.) contains phenol IP 27.9% v/v, clove oil IP 18.6% v/v, Camphor IP 14.0% w/v, oil Menthol IP 18.6% v/v, Azowan oil (IP 66) 2.3% v/w, non aqueous base 100%. The oil preparation named xe2x80x9cClove oilxe2x80x9d (from Dabur India Ltd.) contains 100% clove oil only. xe2x80x9cDant Dard ki Dawaxe2x80x9d (from Baidyanath Ayurved Bhawan) contains phenols IP 1% w/v, Camphor (IP, 66) 5% w/v, Thymol IP 22.5% w/v, Chloro butanol IP 1% w/v, Clove oil IP 25% v/v, Chloroform Sp. IP q.s. Alcohol content 48-52% v/v. xe2x80x9cDanta Besharixe2x80x9d (from Baidyanath Ayurved Bhawan) contains Tannic acid IP 10% w/v, Phenol IP 1% w/v, Clove oil IP 0.05% v/v, cinnamon oil (IP66) 0.25% v/v, glycerin IP 100% v/v.
Dantacare (from Kothari Laboratories) contains Borex 0.28%, Methyl salicylate 0.16%, clove oil 16%, Tannic acid 0.32%, potassium iodide 2.088%, Camphor 0.24%, Phenol 0.14%, Thymol 0.28%, chloroform 0.3%, Menthol 0.20%.
Each ml of Dantaolina (by Jupiter Pharmaceutical Ltd.) contains: Creosote 5%, Clove oil 5%, Tinct. Mayrrh 5%, Tinct. Iodine 25%. Procaine HCl 0.5%, Camphor 0.5%, Glycerolin 50%, Chloroform 30% and Dentosol (Prepared by Synthochem Pharmaceuticals) contains (in 5 ml) camphor 30 mg, menthol oil 0.1 ml, Thymol 30 ml, Clove oil 0.15 ml, Katha 50 mg, Syrup 4.57 ml.
All the above mentioned products have clove oil along with other ingredients like camphor, Thymol and menthol. In four preparations Dar-Dant, Denta care, Dant Dard Ki Dawa and Dentolin one or more synthetic chemicals have been used. While Denta Beshari of Baidyanath Ayurved Bhawan have cinnamom oil as one component, which possess cinnamaldehyde as major ingredient. Cinnamaldehyde is reported to produce dermatitis and have mutagenic activity. For pure natural formulation Dabur has utilized pure clove oil while Dentosol produced by Synthochem have Katha (Acacia catechu), which has not a agreeable taste and may not be liked by all. Moreover, most of these formulations contain phenol which is toxic in higher concentrations.
A histological study was carried out to determine whether zinc oxide oil of clove and zinc oxide eugenol preparation used to manage dental cavities near the pulp effect the cells when compared with healthy pulp; short term studies 2-3 days and long term studies 4-5 weekly, indicated no harmful effects from either materials. The paper titled xe2x80x9cEffects on tooth pain zinc oxide clove oil or zinc oxide eugenolxe2x80x9d by Guelzow, H. J. Struepig W. (A. V. Zahnerhaltungaskd. Uni. Hamburg zoo Hemburing Fed. Rep. Ger) Dtsch zahnacerth Z. 1981 368: 475-7 (Ger) (CA 95, 175745K) gives the result of the study. Although this paper indicates that zinc oxide clove oil and zinc oxide eugenol have no harmful effects, but there is no indication that pain due to dental caries get relieved by this formulation. Zinc oxide being an inert substance and generally used for coatings in cosmetics can""t be of any help in relieving the pain due to dental caries.
Japanese Patent 9500,110,20 xe2x80x9cComposition for oral cavity and periodental diseasesxe2x80x9d by Nishida et al. describes a compound (dentrifrices) for oral cavity and periodental diseases containing antibody (to cavity or periodental diseases related microorganisms) selected from those present in blood, egg and milk, menthol, a flavor compound selected from carvone, anethol, cineole, methyl salicylate, geraniol, ethyl butyrate and cinnamaldehyde in the ratio 4:1 to 2:8 by Wt. The compound is excellent for antibody stability, can produce satisfactory antibody effect even after being stored for long time and gives comfortableness in its use. The use of anethol, cineol, menthol, ethyl tartarate and cinnamaldehyde in combination with antibodies of blood, egg and milk indicates its obviousness against antibodies to cavity periodental diseases related to microorganisms. The formation can""t give instant relief to the aching tooth.
Phenol, camphor, clove oil, menthol and eucalyptus are dentist""s remedies for pulpitis. Dentist also employ alcohol, Thymol, cinnamol oil and oil of winter-green as pain relievers during pulpitis. In a paper titled xe2x80x9cThe sedative action on toothache by reagents used on the Pulpxe2x80x9d by Tutsumi Nagira and Torroyo Folia Pharmacol, Japan 9(4), 262-72 and ibid 12 (1), 82-88, 1930, the sedative effect produced by Phenol, camphor, clove oil menthol and eucalyptus in rabbits having artificial toothache was investigated. It was found that Phenol shows the strongest action, but it can cause oral irritation. Clove oil, menthol and eucalyptol are weak and camphor has no sedative effect. In another experiment in the same paper, the pain-reliving activity of alcohol, Thymol, cinnamol oil and oil of winter-green were investigated. It was found that pain-relieving activity of creosote was the most efficient, but creosote cannot be used as it is toxic and is generally used as disinfectant. Thymol, oil of winter-green and oil of cinnamon were very weak and alcohol has almost no effect.
The main object of this invention is to provide a process for the preparation of a composition of an herbal liquid dentrifrices for quick pain relief in the aching tooth.
Another object is to give a refreshing effect to the oral cavity after its application. Yet another object is to check the growth of bacteria in normal teeth.